Real-World Evaluation of Cannabis-Based Medicines (mCannabis.RealWorld) - Alberta Innovates

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What is it?

The mCannabis.RealWorld Program is a novel enabling mechanism to address urgent clinical or policy knowledge gaps related to the efficacy and safety of cannabis in a real-world setting.  The current approach supports post-market (i.e., after regulatory approval) studies using real-world data and builds on the success of the Exploring Cannabis-Based Medicines and Tools (mCannabis) Program. Real-world data are sources of information collected outside of conventional randomized clinical trials.  This type of information can provide evidence about the health outcomes of diverse patient populations in a real-world setting and provide important economic insights to inform clinical or policy decisions. 

The figure below outlines a typical drug development process and how AB Innovates’ strategy for addressing knowledge gaps.

Highlights 

The mCannabis.RealWorld Program is the first of its kind.     

unique feature of the mCannabis.RealWorld Program is an opportunity to engage with a panel of industry members, academics, clinicians, research facilitators, and other health care agents to strengthen full proposals as well as identify collaborative opportunities.  

Current members and data resources (supplied by volunteer panel members) are found in the table below.

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MemberRole & AffiliationData Resources
David BergPresident & CTO, StrainprintData Dictionary

Company Overview
Don Reynolds Director, Headset Market sales data dictionary
Helen Stevenson

Edward Collins
CEO, Reformulary Group


VP, Business Development, Reformulary Group
Cannabis-related data description

Drug claims data dictionary
Kit Poon Director, ARBRLiterature-based data dictionary
Michael Colbourne CEO, NeobiMarket sales data dictionary
Nancy White

Sigrun Watson
CEO, Inagene Diagnostics


VP, Sales and Marketing, Inagene Diagnostics
Pharmacogenetics data summary
Dr. Jeremy Beach

Ed Jess
Assistant Registrar, Physician Health Monitoring Program, College of Physicians and Surgeons of Alberta

Chief Innovation and Analytics Officer, College of Physicians and Surgeons of Alberta
Dr. Robert TanguayPresident, Pain Society of AlbertaCommonly used, clinically validated questionnaires
Dr. Finlay McAlister



Dr. Hude Quan


Dr. Maria Santana
Lead, Data Platforms, Alberta Strategy for Patient Oriented Research SUPPORT Unit (AbSPORU)

Lead, Methods Development, (AbSPORU)


Lead, Patient Engagement, (AbSPORU)
Alberta Health Data Asset Directory (2018)

Alberta admin datasets (2017)

Link to top seven databases

Overview
Dr. Lawrence Richer

Dr. Scott Klarenbach
Director, Northern Alberta Clinical Trials & Research Centre (NACTRC)


Director, NACTRC Real World Evidence Unit
Process overview
Dr. Sana-Ara AhmedAnesthesiologist, Pain & Cannabinoids Specialist, Genuvis Health
Dr. Luisa BartonNurse Practictioner & Clinical Manager, Athabasca UniversitySample of cannabis consult intake form

Sample of initial medical cannabis consult note
Dr. Tawyna HansenGastroenterologist, University of Manitoba
Mark Diner Director, Alberta Data Institute

Benefits

Applicants who participate in mCannabis.RealWorld can expect the following outcomes

  • Generate real-world evidence to inform clinical or policy decisions.   
  • Build collaborative connections within the health innovation ecosystem.
  • Improve Canadian competitiveness in the global cannabis sector.   
  • Enable rapid knowledge generation using digital health strategies.  
  • Create accessible new data sources related to medical cannabis use. 
  • Enhance patient-centred care.     

Eligibility

  • Projects led by post-secondary institutions, not-for-profit corporations, or health delivery agent in Alberta. 
  • Must address a clearly defined and major clinical or policy problem, need, or critical barrier that has relevance to Alberta.
  • Seek to generate new data, analyze data relationships, or curate real-world data to support the problem. 
  • See program guide for full details.

Funding  

Alberta Innovates will contribute up to $300,000 CAD to support approved projects over a maximum term of 24 months. Successful Expression of Interest applicants will be eligible to receive up to $10,000 CAD to support proposal development.

Important dates – Apply now! 

  • Expression of Interest (Stage 1) deadline: October 7th, 2020 at 4:00 PM MST 
  • EOI decision: Early November 2020 
  • Strengthening Panel dates:  23 and 26 November 2020 (Expected
  • Full Proposal (Stage 2) deadline: December 16th, 2020 at 4:00 PM MST 
  • Full Proposal Decision: February 2021 
  • Agreement: March 2021 

Application process 

  1. Expression of Interest (Stage 1) Application (please consider the data resources in the table above).
  2. Successful EOI Applicants present at strengthening panel session. 
  3. Advance to Full Proposal (Stage 2) Application.

Please note that you will need to create an account to access our online application portal. If you have any questions about the application process or concerns about your project’s eligibility, feel free to contact Alberta Innovates at any time.

Application resources